Actively Recruiting
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Led by Janssen Research & Development, LLC · Updated on 2026-05-08
600
Participants Needed
69
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).
CONDITIONS
Official Title
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Medically stable based on physical exam, medical history, vital signs, and ECG at screening
- Clinical diagnosis of systemic lupus erythematosus (SLE) for at least 24 weeks prior to screening according to EULAR/ACR criteria
- SLEDAI-2K score of 6 or higher and clinical SLEDAI-2K score of 4 or higher at screening and Week 0, excluding points for lupus headache, alopecia, and organic brain syndrome
- Negative serum beta human chorionic gonadotropin (\u03b2-hCG) test at screening and negative urine (\u03b2-hCG) test at Week 0 for participants of childbearing potential
- At least 1 BILAG-2004 A score or 2 BILAG-2004 B scores at screening
You will not qualify if you...
- History of severe, progressive, or uncontrolled liver, gastrointestinal, kidney, lung, heart, psychiatric, neurological, musculoskeletal disorders, hypertension, or other uncontrolled autoimmune disorders
- Unstable or progressive SLE manifestations likely to require therapy beyond allowed background medications
- Confirmed or suspected immunodeficiency syndrome unrelated to SLE treatment or family history of congenital/hereditary immunodeficiency unless confirmed absent
- Previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins
- Known or suspected allergies, hypersensitivity, or intolerance to nipocalimab or placebo excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 69 locations
1
David S Hallegua MD A Professional Corporation
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis
Hemet, California, United States, 92543
Actively Recruiting
3
Advanced Medical Research
La Palma, California, United States, 90623
Actively Recruiting
4
Solace Clinical Research California
Tustin, California, United States, 92780
Actively Recruiting
5
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States, 91786
Actively Recruiting
6
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
Actively Recruiting
7
Clinical Research of West Florida 1
Clearwater, Florida, United States, 33765
Actively Recruiting
8
Avanti Clinical Research Corp
Hialeah, Florida, United States, 33013
Actively Recruiting
9
LeJenue Research Associates PLLC
Miami, Florida, United States, 33126
Actively Recruiting
10
Floridian Clinical Research LLC
Miami Lakes, Florida, United States, 33016
Actively Recruiting
11
Clinical Research of West Florida
Tampa, Florida, United States, 33606
Actively Recruiting
12
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois, United States, 60527
Actively Recruiting
13
Accurate Clinical Research, Inc.
Lake Charles, Louisiana, United States, 70605
Actively Recruiting
14
Joint and Muscle Research Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
15
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States, 28211
Actively Recruiting
16
Cross Creek Medical Clinic
Fayetteville, North Carolina, United States, 28304 4422
Actively Recruiting
17
Paramount Medical Research & Consulting
Middleburg Heights, Ohio, United States, 44130
Actively Recruiting
18
Clinical Research Philadelphia
Philadelphia, Pennsylvania, United States, 19114
Actively Recruiting
19
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
Actively Recruiting
20
Arthritis and Rheumatology Research Institute
Allen, Texas, United States, 75013
Actively Recruiting
21
Amarillo Center for Clinical Research
Amarillo, Texas, United States, 79124
Actively Recruiting
22
R and H Clinical Research
Katy, Texas, United States, 77449
Actively Recruiting
23
Southwest Rheumatology Research LLC
Mesquite, Texas, United States, 75150
Actively Recruiting
24
Texas Rheumatology Research Institute LLC
Plano, Texas, United States, 75024
Actively Recruiting
25
ARCIS Salud SRL Aprillus asistencia e investigacion
Buenos Aires, Argentina, C1406AGA
Actively Recruiting
26
Centro Privado de Medicina Familiar
Buenos Aires, Argentina, C1417EYG
Actively Recruiting
27
Centro de Investigacion en Enfermedades Reumaticas CIER
Ciudad de Buenos Aires, Argentina, C1055
Actively Recruiting
28
Arsema
Ciudad de Buenos Aires, Argentina, C1427
Actively Recruiting
29
Instituto de Investigaciones Clinicas Quilmes
Quilmes, Argentina, B1878GEG
Actively Recruiting
30
MR Medicina Reumatologica
San Fernando, Argentina, B1646GHP
Actively Recruiting
31
Hospital das Clinicas - UFG
Goiânia, Brazil, 74605-020
Actively Recruiting
32
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil, 90035-903
Actively Recruiting
33
LMK Servicos Medicos S S
Porto Alegre, Brazil, 90480 000
Actively Recruiting
34
Fundacao do ABC Centro Universitario FMABC
Santo André, Brazil, 09060 870
Actively Recruiting
35
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
São José do Rio Preto, Brazil, 15090 000
Actively Recruiting
36
ESHO Empresa De Servicos Hospitalares S A
São Paulo, Brazil, 01232 010
Actively Recruiting
37
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
38
Linfen Central Hospital
Linfen, China, 041000
Actively Recruiting
39
Ningbo medical center lihuili hospital
Ningbo, China, 315041
Actively Recruiting
40
Shenshan Medical Center Memorial Hospital of Sun Yat Sen University
Shanwei, China, 516601
Actively Recruiting
41
Shanxi Bethune Hospital
Taiyuan, China, 030032
Actively Recruiting
42
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
43
Carmel Medical Center
Haifa, Israel, 3436212
Actively Recruiting
44
Hadassah Ein-Qarem Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
45
Meir Medical Center
Kfar Saba, Israel, 4428164
Actively Recruiting
46
Galilee Medical Center
Nahariya, Israel, 2210001
Actively Recruiting
47
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
48
Tokai University Hospital
Isehara, Japan, 259-1193
Actively Recruiting
49
Shinkenko Clinic
Naha, Japan, 900 0015
Actively Recruiting
50
St. Luke's International Hospital
Tokyo, Japan, 104 8560
Actively Recruiting
51
Hospital Sultan Ismail
Johor Bahru, Malaysia, 81100
Actively Recruiting
52
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Actively Recruiting
53
Hospital Umum Sarawak
Kuching, Malaysia, 93586
Actively Recruiting
54
Sunway Medical Centre
Petaling Jaya, Malaysia, 47500
Actively Recruiting
55
Hospital Taiping
Taiping, Malaysia, 34000
Actively Recruiting
56
NTU Biomedical Park Hospital
Hsinchu, Taiwan, 302058
Actively Recruiting
57
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813414
Actively Recruiting
58
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
59
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
60
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
61
Ankara University Medical Faculty
Ankara, Turkey (Türkiye), 06050
Actively Recruiting
62
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
63
Firat University Hospital
Elâzığ, Turkey (Türkiye), 23200
Actively Recruiting
64
Sanko Universitesi Hastanesi
Gaziantep, Turkey (Türkiye), 27090
Actively Recruiting
65
Marmara University Istanbul Pendik Education and Research Hospital
Istanbul, Turkey (Türkiye), 34899
Actively Recruiting
66
Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey (Türkiye), 42080
Actively Recruiting
67
Peterborough City Hospital
Peterborough, United Kingdom, PE3 9GZ
Actively Recruiting
68
Southampton University Hospital
Southampton, United Kingdom, SO16 6HU
Actively Recruiting
69
Haywood Hospital
Stoke-on-Trent, United Kingdom, ST6 7AG
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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